|UNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)|
|BANGKOK, THAILAND, 20-22 APRIL, 1998|
Informed consent should ultimately be provided by the individual participant. The issue of informed consent was felt to have been inadequately covered by the study questions and during discussions, given its importance in the ethical conduct of trials.
In the context of discordant couples (the case presented in the scenarios), the group agreed that family and community would need to be involved in the individuals final decision to participate, and many thought that the sexual partner of the vaccinee should also provide informed consent.
Regarding those who suffer from mental disorders, the group agreed that they should not be enrolled in a trial under any circumstances. This does not preclude these individuals receiving a vaccine that has been proven effective following completion of an efficacy trial.
Groups that may have difficulty in giving individual informed consent include bonded sex workers, prisoners, and military recruits.
Differences between the informed consent process in Asia and the West were discussed. There was a strong sentiment among representatives of Asian countries that the degree to which communities must be involved in the decision-making process of the participant and the influence of community leaders on the individuals decision are greater in the East than in the West. There was also concern that study participants in Asia (particularly in rural communities) are more likely to make decisions based on the opinion of the community or its leader than on a thorough understanding of the study protocol. Representatives of Western countries argued that this also occurs in the West, and that the difference between the two cultures is unlikely to be significant. This issue surfaced several times during the workshop.